Polymedix commences Phase 1B study of novel anticoagulant reversing agent

PolyMedix, Inc. (OTC BB: PYMX, http://polymedix.com), an emerging biotechnology company developing new therapeutic drug products to treat infectious diseases and acute cardiovascular disorders based on biomimetics, has initiated dosing and commenced a second clinical trial, a Phase 1B pilot proof of concept study, in the U.S. with its anticoagulant reversing agent PMX-60056 under an Investigational New Drug application (IND) filed with the U.S. Food and Drug Administration (FDA). PMX-60056 represents a new class of drug, which PolyMedix calls a heptagonist, and is believed to be the only reversing agent for heparin and the Low Molecular Weight Heparins (LMWH) in clinical development.

The second clinical trial is being conducted in healthy volunteers, and will involve first administering heparin to healthy subjects, and then afterwards administering a single dose of PMX-60056. This study is intended primarily to assess the safety of using PMX-60056 in heparinized subjects, and will also measure the ability of PMX-60056 to neutralize heparin and normalize blood clotting time. This study is utilizing a crossover double-blind design, and is planned to be conducted in a total of six subjects. Results are expected by the end of 2009. Following this clinical trial, significant additional clinical studies and regulatory submissions will be required to obtain regulatory approval from the FDA and other regulatory bodies before PMX-60056 could be commercially sold.